The FDA recently announced that a major medical technology company, Stryker, will be voluntarily recalling its Rejuvenate and ABG II modular-neck stems medical devices. The recall will take place after data indicated the potential for corrosion at the modular-neck junction that can cause tissue problems in patients.
Stryker notified regulatory bodies and doctors of the recall just last week. The company is saying that the number of complications with modular-neck stems is low. Patients who have complained of trouble have experienced pain and swelling at the site of the device while others have experienced aseptic loosening, which can loosen the bond between the implant and the bone.
The product is a two-part modular-neck system that consists of a metal neck inside a metal state. The report says that any patient who experiences pain not linked to a known cause should seek out treatment and evaluation. Part of that treatment should include serum metal ion levels, metal hypersensitivity testing and radiographic analysis.
Worryingly, the issues associated with modular-neck hip implant systems are similar to those seen among recipients of metal-on-metal hip replacement devices. A number of studies have show that recipients of metal-on-metal hip implants may face a significant risk of developing serious complications including tissue damage, device failure, need for revision surgery and long-term disability due to the corrosion and spread of metal ions into the bloodstream from the implants.
Just this year the British Medical Journal issues a report regarding the potentially high levels of metallic ions released by all-metal hip implants and the dangers that may present. Another study published in The Lancet called for a ban of the all-metal devices after finding significantly higher failure rates than in devices made of ceramic or plastic. Finally, the Journal of Arthroplasty recently published a study showing that metal-on-metal implants corrode faster than metal-on-polyethylene, a problem faced by hip transplant patients and now a worry for those with neck implant devices.
If you are a patient who has received a Rejuvenate Modular or ABG II modular-neck stem, please contact your surgeon. If you or someone you love has had one of Stryker’s recalled modular neck-stems implanted and experienced pain, you may be entitled to compensation. Please contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.